MAUDE Adverse Event Report: DAVOL, INC., SUB. C.R. BARD, INC. CR BARD MESH PLUG; MESH, SURGICAL, POLYMERIC

Model Number FALSIFIED ON SURGICAL REPORT

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Aeromonas hydrophila (b)(6) seafood chowder counterfeit mesh by (b)(6).This is an add on to the report i just submitted because it does not appear that you took my email i see (b)(6) was there when this was initially reported, i have no problem saying hhs/fda-oig cover up makes him culpable.Refer to us doj criminal prosecutions or (b)(6); he puts judges in prison too.So does (b)(6) (ref, (b)(6)).(b)(6) is lawyer and a politician-that makes this form nothing more than data collection- he¿s not my representative, my advocate and his education makes him evil.So forward to potus and tell him this is no different than the tree of life shootings; i think the shooter is getting death row.I expect the same.Fda oig already gave my name to manufacturer; resulted in terroristic threats, obstruction of justice, witness tampering (threats to me are recorded as evidence) do not do it again or you¿ll sec of hhs also be included in this case.Food (b)(6) seafood chowder; device-crbard mesh plug&panel (falsified).(b)(6) fish market; cr bard davol.Cascade of deleterious effects from no consent counterfeit mesh; it¿s an endocrine system disruptor.Spinal cord injury from ¿cover up-perpetrators¿.No prescription meds (can¿t digest enteric coatings); medical implant not completely explanted (your crime; not mine).I believe your agency is copying me- you have to pay for it which is why i expect (b)(6) to be indicted.Fda safety report id # (b)(4).Fda received date 02/17/2020.

• Brand Name: CR BARD MESH PLUG
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): DAVOL, INC., SUB. C.R. BARD, INC.
• MDR Report Key: 9753287
• MDR Text Key: 181408195
• Report Number: MW5093265
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FALSIFIED ON SURGICAL REPORT
• Device Catalogue Number: FALSIFIED ON SURGICAL REPORT
• Device Lot Number: FALSIFIED ON SURGICAL REPORT
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 52